Cleared Traditional

K110761 - MICT TSH

K110761 is an FDA 510(k) clearance for MICT TSH, manufactured by Magnabiosciences, LLC. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K110761 · Magnabiosciences, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
357d
Days
Class 2
Risk

K110761 is an FDA 510(k) clearance for the MICT TSH. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Magnabiosciences, LLC (San Diego, US). The FDA issued a Cleared decision on March 9, 2012 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Magnabiosciences, LLC devices

FDA 510(k) Submission Details - K110761

510(k) Number K110761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2011
Decision Date March 09, 2012
Days to Decision 357 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 88d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JLW Device Classification - Class 2, Special Controls

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 186
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